Fundoplication surgery works far better than continuous drug treatment for gastroesophageal reflux disease refractory to proton pump inhibitors (PPIs), as long as other conditions that can cause heartburn are carefully ruled out, a new study suggests.
"Fundoplication had fallen from favor with gastroenterologists, largely because it had been used inappropriately and can have bad side effects," said Stuart Spechler, MD, from the Baylor University Medical Center in Dallas. "But gastroenterologists have to appreciate that there is a role for invasive treatment in this disease."
Up to 40% of patients with reflux symptoms treated with PPIs deal with persistent symptoms, and there are few treatment options for this group, Spechler told the crowd of about 1800 people here at Digestive Disease Week 2018.
"We have to get out of the mindset that there's nothing we can do for these patients," Spechler told. "We've been doing our patients somewhat of a disservice by not recommending reflux surgery when appropriate."
He and his colleagues recruited 366 patients with heartburn refractory to medical therapy from 10 Veterans Administration centers. However, rigorous screening determined that in 288 cases, the heartburn stemmed from another cause.
Just 78 patients 21% of the original cohort proceeded to randomization. Of these, 27 underwent laparoscopic Nissen fundoplication; 25 received active medical treatment with 20 mg of the PPI omeprazole twice daily plus up to 20 mg of baclofen three times daily or, in the case of baclofen failure, up to 100 mg of desipramine at bedtime; and 26 received placebo.
Nonreflux Disorders Causing Heartburn
The rigorous testing to exclude non-reflux disorders that can cause heartburn, such as eosinophilic esophagitis, achalasia, and heart or biliary disease which PPIs do not always eliminate included endoscopy with esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance with pH monitoring.
"It was illuminating to see the small number of participants that remained after exclusion. It is good to find out that reflux isn't the cause of ongoing heartburn in a lot of cases, so we don't end up doing an invasive procedure," Spechler added.
"The low number of participants who had PPI-resistant reflux is striking," said Ikuo Hirano, MD, from the Feinberg School of Medicine at Northwestern University in Chicago.
"The take-home message I got, which is an important message, is that the majority of patients who went into this trial labeled with refractory reflux did not have acid reflux as the cause of their symptoms," Spechler told.
"To translate that to clinical practice, if a patient has ongoing symptoms while on PPI therapy, it makes sense to think of non-reflux causes of ongoing symptoms," said Spechler.
However, for the participants who received active medical therapy, the medications combined with the low-dose PPI tend to induce sleepiness as a major adverse effect, making this a "practical limitation" of the study, Hirano explained.